Official recall record
AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant components manufactured from UHMWPE (polyethylene
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2026-07-30
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Howmedica Osteonics Corp.
What the authority reported
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-29.
Record last checked against the registry on 2026-09-29.
Other recalls from this brand
- 2026-07-30 · US FDA — Medical Devices
OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic implant components manufac - 2026-07-30 · US FDA — Medical Devices
SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-371 - 2026-07-30 · US FDA — Medical Devices
ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE
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